EFPIA for Greater Patient Safety

Counterfeit medicines are an increasing threat to the EU supply chain and there is need for a standard identification solution across Europe. The European Federation of Pharmaceutical Industries and Associations (EFPIA) explains the threat of counterfeit medicines and what the industry is doing to reduce the danger.

The threat of falsified medicines penetrating the European supply chain is substantial and growing. According to statistics from European Customs, the number of medicines seized at the point of entry into the EU rose three-fold over the period 2006–2009 to some 7.5 million items. In 2010 alone, more than 3.2 million medicines were confiscated, representing more than 3% of all items seized at EU borders. How many falsified medicines have actually effectively penetrated the supply chain is a matter of conjecture in the absence of an effective tool to prevent their entry.

The adoption on July 1, 2011 of the "Falsified Medicines Directive" (FMD) is an important step in better protecting patients from counterfeit medicines. The Directive introduces mandatory, harmonised pan-European safety features in the form of tamper-evident packaging and a "unique identifier" that will be applied to all prescription medicines, subject to possible exclusions based on risk assessment. Tamper-evidence features together with a unique serial number on each medicine pack will enable pharmacists to check whether a pack has been tampered with and previously dispensed, alerting them to any risk of counterfeiting. To ensure maximum effectiveness, however, it is vital that all medicine packs are verified systematically at pharmacy level.

The European Commission (EC) will define the mechanics of how this system will work in Delegated Acts that are to be adopted by the end of 2012. The Delegated Acts will define the characteristics and technical specifications of the "unique identifier", which will enable identification of individual packs, and the accessibility of national product databases or repositories to verify each dispensed pack.

EFPIA, together with GIRP (Groupement International de la Répartition Pharmaceutique) and PGEU (Pharmaceutical Group of the European Union), the respective European organisations of wholesalers and pharmacists at EU level, fully support this legislation and will be pleased to work with the EC in establishing an effective system in the interests of patient safety. To this end, they have proactively initiated a project to identify concrete options for establishing a stakeholder-governed model for the verification of pharmaceutical products in Europe. The aim is to set up a cost effective and scalable pan-European product verification system that is to be run by stakeholder organisations on a non-profit basis.